Friday, June 27, 2008

For the first time, to the best of my knowledge, an anti-smoking group has publicly and officially called for a ban on smoking in all homes, suggesting that this is the next front in the war against smoking.

In a press release issued on Wednesday, Action on Smoking and Health (ASH) - a Washington, D.C.-based national anti-smoking group - called banning smoking in homes the next front in the war on smoking and cited a new survey showing that a majority of people in Ireland expressed support for a total ban on smoking in homes and cars.

According to the press release: "A clear majority wants smoking banned in all homes, even if children are not present, and even if the smoke is not drifting into an adjoining dwelling. This could expand the latest front in the war to protect nonsmokers, says the man who started the nonsmokers' movement by getting smoking first restricted and then banned on airplanes and then in workplaces and public places, and who is racking up victories in the battle to ban smoking in private dwellings and cars. According to a new survey, 57% of the people in Ireland support a ban on smoking in all homes and cars."

"This could indicate growing support for smoking bans both here and abroad, says public interest law professor John Banzhaf of Action on Smoking and Health (ASH) -- America's first antismoking organization, and the group behind restrictions on smoking in homes in almost three fourths of the states -- because the percentage of smokers in Ireland is substantially higher than in the US." ...

"'As politicians in many states continue to debate whether to ban smoking in restaurants, bars, casinos, and other public places, it looks like legislators are once again far behind the growing public sentiment for smoking bans, and also far behind how far judges and regulatory agencies are willing to go,' says Banzhaf. ... Since restrictions of smoking are one of the most effective -- and virtually the least expensive -- way to help smokers quit, it is no surprise that there is growing support for smoking restrictions, even if no nonsmokers' health is being put at risk by the smoking, suggests Banzhaf."

The Rest of the Story

This is an important story and perhaps a sentinel moment in the history of the tobacco control movement because to the best of my knowledge, this is the first time that an anti-smoking group has publicly and officially called for a ban on smoking in all homes and suggested that this is the next front in the war against smoking.

This is a troubling development for many reasons. For one, banning smoking in homes for the purpose of protecting children from secondhand smoke exposure is an appallingly bad place to be in terms of public health policy. It represents an undue invasion of privacy and as well as an unwarranted interference with parental autonomy to make their own decisions regarding health risks to which their children are or are not exposed.

Banning smoking in homes to protect children would be qualitatively no different from prohibiting parents from taking their kids to fast food restaurants, feeding them food containing trans-fats, allowing them to engage in risky activities like ice hockey or football, allowing them to watch violence-ridden movies and play violence-ridden video games, letting them go to R-rated movies, and not forcing them to get enough physical activity.

Clearly, these other behaviors are not ones which society would choose to regulate. Smoking in the home is qualitatively the same. If one supports a ban on smoking in the home in order to protect children's health, then the same reasoning would lead to support for a ban on each of these other parental behaviors, which would clearly be unacceptable.

Second, banning smoking in homes in order to reduce smoking is even less acceptable. That would be a complete invasion of privacy and autonomy. It would represent completely unenlightened paternalism. Public health practitioners need to remember that there are other important values that need to be preserved in society beyond merely getting people to stop smoking. We also need to make sure that our interventions respect individual autonomy, freedom, and privacy. Banning smoking in homes to reduce smoking rates violates all three of these principles.

What scares me most about ASH's latest pronouncement is not merely ASH's support for this policy. I don't think that ASH's support alone would be enough to convince policy makers to enact such policies. However, what scares me the most is that if no other anti-smoking groups speak out publicly to reject ASH's statement, this will become the de facto policy position of the tobacco control movement. And because, as I have learned, dissent is not allowed in tobacco control and you cannot criticize another group in the movement, I fear that no anti-smoking groups will speak out to condemn ASH's support for banning smoking in homes.

I must also say that ASH is making the pronouncements of smoking ban opponents look good. Many years ago, when I was lobbying for smoke-free workplace laws, opponents of these laws argued that this was just the first step: workplaces were the first step and eventually we [the antis] would be trying to get smoking banned in the home. I countered these arguments by stating no - you're wrong - we are going to stop after getting smoking banned in the workplace. Unfortunately, it looks like I was wrong and the smoking ban opponents were correct. Thanks to ASH, all those smoking ban opponents can now say "I told you so."

Why would ASH make a public statement like this? Wouldn't ASH recognize that by doing this, it paints all anti-smoking advocates and groups as being complete fanatics whose ultimate goal is to ban smoking everywhere, even inside the home? Doesn't ASH recognize that its action is going to give smoking ban opponents great ammunition in their fight to oppose these ordinances - that they can now point to ASH's press release as evidence that the ultimate goal of the tobacco control movement is indeed to ban smoking everywhere, including the home?

This action by ASH puts a significant dent in the legitimacy of not only the tobacco control movement, but of public health in general. The only way to prevent damage from occurring would be if the public merely views ASH as a fanatic group that has gone off the deep end. But that will not happen unless other anti-smoking groups are willing to publicly condemn ASH's support for banning smoking in the home. As I don't see that happening due to the poisonous groupthink mentality in the tobacco control movement, I fear that ASH's action will damage the legitimacy of tobacco control.

Finally, I must note that it strikes me that ASH's actions appear to be motivated by something more than simply a concern for the health of smokers. Instead, I get the distinct impression that ASH is acting, at least in part, out of pure hatred for smokers and a desire to punish them. It seems to me like one can feel the hatred oozing out of the press release and that ASH is trying to punish smokers in any way it can find - no matter how much damage that might cause to the children of those smokers or to societal values like privacy and autonomy.

ASH seems to think that it is more important for kids to be protected from even the smell of tobacco smoke on a parent's clothing than for those kids to have a parent to be with in the first place. ASH's priorities are completely out of whack. And unless other anti-smoking groups speak out now, so will - by default - the priorities of the tobacco control movement. In some sense, we are only as strong as our weakest link. By pushing for home smoking bans, ASH is unfortunately painting the entire tobacco control movement as fanatics whose ultimate goal is to ban smoking everywhere. We can't prevent the movement from being successfully painted in that way unless we speak out and distance ourself from that paint brush.

Thursday, June 26, 2008

Health Canada has produced a "Smokefree Spaces" activist toolkit to encourage school children in Canada to advocate for smoke-free places in their communities. One of the recommended activities is for the children to produce secondhand smoke-related "research facts" to educate the members of their community.

Health Canada provides the following as an example of a research "fact" that should be used: "A non-smoker in a smoky room, such as a bar, inhales the equivalent of 35 cigarettes an hour."

The Rest of the Story

It is far from a "fact" that nonsmokers in a smoky bar inhale the equivalent of 35 cigarettes an hour. In fact, it is false.

In terms of nicotine exposure, a nonsmoker in a smoky bar inhales the equivalent of less than one-thirtieth of a single cigarette in an hour. So clearly, you cannot accurately claim that a nonsmoker in such a situation inhales the equivalent of 35 cigarettes an hour. You are in fact in error - and by a whopping factor of about 1000. You're off by three orders of magnitude!

It is true that in terms of some smoke constituents - notably NDMA - which is much more concentrated in secondhand smoke than mainstream smoke, nonsmokers in a smoky bar may inhale the equivalent of about 2 cigarettes an hour. But even for NDMA, this "fact" is off by a factor of about 17.

I have no clue where the 35 cigarettes per hour figure comes from, but it is undoubtedly inaccurate. Even if one excludes from consideration all other constituents than NDMA - which is highly misleading - this statement is not accurate. But since the statement refers to overall exposure and not a particular constituent (it doesn't mention any particular constituent), it doesn't even come within a factor of 17 of being correct.

It is just inaccurate to assert that being exposed to tobacco smoke in a smoky bar for an hour is equivalent in terms of exposure to actively smoking 35 cigarettes.

And it is also irresponsible. This undermines the hazards of active smoking. Do we really want smokers to believe that smoking close to 2 packs of cigarettes per day is no worse than sitting in a smoky bar for an hour (and not smoking)?

So this "research fact" turns out not only to be false, but also to send a message that undermines decades of education about the severe hazards of smoking. If the children of Canada actually follow Health Canada's advice and disseminate this message, it may well undermine the government's important health message about the severe hazards of active smoking.

After all, if I were an active smoker of about 2 packs per day and I found out that my smoking was no worse than being a nonsmoker in a bar for an hour a day, I would conclude that the health effects of smoking are not as bad as they were made out to be.

I don't understand why Health Canada needs to use a false piece of information as an example to children. Are they trying to encourage students to exaggerate and distort the facts as anti-smoking groups are known to do? Are they honestly not aware that sitting in a bar for an hour is not the same thing as actively smoking 2 packs of cigarettes per day? Do they sincerely believe that the exposure in these two situations is identical? Or have they just been sloppy and not really thought about it?

I don't know the answer, but the question is quite clear: why is Health Canada providing a piece of false information to children and encouraging them to disseminate this information?

Incidentally, I am in a decent position to criticize this statement, since I myself have made statements about the cigarette equivalents of secondhand smoke exposure. However, in doing so, I have always been careful to specify exactly what constituent I was talking about. For example, if data shows that working in a smoky bar for 8 hours produces the same NDMA exposure as actively smoking one pack of cigarettes, then I have made it clear that NDMA exposure is what I am talking about. I have never suggested that secondhand smoke exposure for eight hours in a smoky bar is equivalent in terms of exposure to actively smoking a pack of cigarettes.

For a more detailed discussion of the dangers of using cigarette equivalents and the misleading health claims by numerous other health and anti-smoking groups, see my previous post.

Wednesday, June 25, 2008

The authors of the study discussed here yesterday which concluded that parents who smoke only outside the home still expose their children to dangerously high levels of tobacco smoke have instructed the public that there is no reason to smoke outside in an effort to protect children from secondhand smoke. As quoted in an article in the Victoria Herald-Sun, the authors told the public that smoking outside the home is pointless; the only way to protect children from tobacco smoke exposure is not to smoke at all.

According to the article: "Lead researcher Dr Krassi Rumchev said when smokers returned indoors, they still breathed out smoke that contaminated the air enough to cause damage. They also brought particles inside on their body and clothes. Dr Rumchev said parents must quit to make their home safe for children. 'If parents would like to provide a smoke-free home environment they have to stop smoking,' Dr Rumchev said. 'Smoking outside just isn't providing the protection that many Australian smokers believe it does.'"

The Rest of the Story

As I explained yesterday, this study is severely and fatally flawed because no effort was made to confirm the self-reported assertions of parents that they only smoke outside the home. The most likely explanation of the study results is not that outdoor smoking causes indoor exposure because of contaminated breath, but that a proportion of the smokers who claimed only to smoke outside were actually lying or stretching the truth and that they do sometimes smoke in the home. The authors of the study dismissed this possibility without any evidence to support that it is not a reasonably likely explanation for the study findings.

This article demonstrates what I predicted yesterday: that anti-smoking advocates will use this flawed study to send the message that parents need not bother to try to refrain from smoking inside the home. It is all or nothing. Either quit smoking completely or you might as well just puff in the faces of your children.

Obviously, this message is nonsense. Of course, quitting is the healthiest option for both the parents and their children. But for the many smokers who either do not want to quit or cannot do so, smoking outside is clearly a much better option than smoking inside the home. And the study in question actually provides no evidence that smoking outside the home is not adequate to protect children from substantial exposure to tobacco smoke inside the home.

To me, this recommendation is irresponsible. If you are going to go out on a limb and make a risky recommendation - one that could endanger the health of many children if it turns out to be wrong - then I think you have the responsibility to make reasonably sure that you are right before you make that recommendation. Here, the authors have failed to do that. They have no evidence to back up their assumption that smokers are all telling the truth. They have not confirmed that all the smokers who claimed to only smoke outside (which was all but 4 of the 39 households) are being truthful, rather than trying to conform to what they see as societal standards or norms.

In public health as in medicine, I believe our first responsibility is to do no harm. Here, I believe that this recommendation from the study authors may well do harm. It may harm children by convincing a number of parents who might otherwise smoke outside that there is no sense to doing so. The end result could well be increased exposure for many children.

If you are going to make a recommendation like this, then you better be reasonably sure that your assumptions are correct. In this case, the authors of the study have made no effort to ensure that their chief assumption - that all study subjects were telling the truth - is correct.

Thus, the rest of the story is that these authors' advice is not only wrong, it is irresponsible.

Action on Smoking and Health (ASH-UK) has a web page on its old web site which attempts to recruit employees who have suffered health damage from secondhand smoke at work to sue their employers. The page, prepared in collaboration with the Thompsons Solicitors law firm, advises the public that if an employee believes he has suffered health damage as a result of secondhand smoke exposure at work, he should consider filing a lawsuit against the employer to receive compensation for personal injuries.

One of the key pieces of information provided by ASH-UK to the public is the following: "Exposure [to secondhand smoke] for just 30 minutes has been shown to reduce coronary blood flow, increasing the risk of angina, heart attacks and strokes."

The Rest of the Story

While ASH-UK has every right to provide information to the public about the health effects of secondhand smoke exposure - information which might lead them to take legal action against their employers, I find it appalling that ASH-UK would provide false information to the public in the hopes that this misleadingly startling data might stimulate lawsuits against employers.

When you get into the area of trying to encourage lawsuits, I think you take on a special responsibility to provide accurate information to the public. ASH-UK has shirked that responsibility.

It is false that 30 minutes of secondhand smoke exposure has been shown to reduce coronary artery blood flow. What brief exposure has been shown to do is to reduce coronary flow velocity reserve (CFVR), which is something very different from coronary artery blood flow. I have already provided a detailed explanation of the important difference between these two and discussed how the conflation of these two entities by anti-smoking groups has led to numerous fallacious health claims.

Briefly, coronary flow velocity reserve is a measure of the ability of the coronary arteries to dilate in order to increase blood flow under experimental conditions. What a decline in coronary flow velocity reserve indicates is something called endothelial dysfunction - an impairment of the ability of the coronary arteries to dilate in response to a variety of stimuli. This ability to dilate is mediated by the endothelial cells -- the cells which line the blood vessel.

The endothelial cells respond to certain stimuli by producing nitric oxide and other chemicals which diffuse into the smooth muscle in the artery wall, sending a chemical message that causes the muscle to relax and therefore causing the artery to dilate. There are a number of exposures that impair the ability of the endothelium to accomplish this function; among them are active smoking, secondhand smoke, high cholesterol, consumption of trans-fats, and consumption of a high-fat meal.

When endothelial dysfunction is triggered repeatedly over a long period of time, it has been shown to result, ultimately, in atherosclerosis (narrowing of the coronary arteries). When this occurs, coronary blood flow is reduced.

It is important to note that a reduction in coronary blood flow is not observed acutely when the endothelial dysfunction is being measured from a single experimental exposure (such as in the Otsuka et al. study). The reduction in coronary blood flow does not occur until the process has been sustained long enough that atherosclerosis has progressed and the coronary artery has actually narrowed. It is the narrowing of the artery that causes reduced coronary blood flow.

A single high-fat meal has been documented to cause endothelial dysfunction. If you were to go to Burger King for a Whopper, fries and a milk shake and then go to a laboratory to have your coronary flow reserve velocity tested, you would find that it is reduced. In fact, it will probably be reduced to the same level as in an active smoker.

Would it therefore be accurate for an anti-obesity group to claim that eating a hamburger reduces coronary artery blood flow in healthy young adults?

I would argue that it would not. In fact, I think such a statement would be very misleading and deceptive to the public.

Instead, what the science shows is that eating a hamburger or any high-fat food causes endothelial dysfunction. Therefore, if you chronically eat lots of fatty foods over a long period of time (many years), the evidence indicates that this could cause atherosclerosis and heart disease. If you do develop heart disease, then your coronary blood flow will be decreased and you will be in danger of possibly suffering a heart attack. But there is no danger of death or a heart attack after simply eating one Whopper.

By conflating coronary blood flow with coronary flow velocity reserve, anti-smoking groups have, I think, been able to deceive people into thinking that the effects of acute secondhand smoke exposure are much more severe than they actually are.

The second part of ASH-UK's statement - that 30 minutes of secondhand smoke exposure has been found to increase the risk of angina, heart attacks, and strokes is also false, or at least very misleading. It is blatantly false that 30 minutes of secondhand smoke exposure increases the risk of angina, heart attacks, or strokes in an otherwise healthy nonsmoker. The only situation in which it is even plausible that brief secondhand smoke exposure could cause angina, heart attacks, or strokes is if the individual has pre-existing severe coronary artery or cerebrovascular disease. Since ASH-UK did not qualify its statement in any way, the public may easily interpret it to imply that it applies to them, even if they do not have severe heart disease or cerebrovascular disease.

There is some evidence that brief secondhand smoke exposure can exacerbate angina symptoms in people with angina (i.e., existing heart disease). However, there is no evidence that it can trigger heart attacks or strokes. This is pure speculation. But ASH-UK is presenting this as fact, stating that it has been shown. In that sense, ASH-UK's statement is demonstrably false.

It is bad enough for ASH-UK to be making false health claims, but to do so in the setting of trying to drum up litigation against employers is appalling.

Tuesday, June 24, 2008

A new study published in this month's issue of Indoor Air concludes that even when parents only smoke outside of the home, toxic smoke constituents in their breath pose a major health risk to their children indoors. This conclusion was based on the finding that: "There were significantdifferences in the median levels of air nicotine and PM10 between households in which smoking was reported as only occurring outside, and the smoke-free households" (see: Rumchev K, Jamrozik K, Stick S, Spickett S. How free of tobacco smoke are 'smoke-free' homes? Indoor Air 2008; 18: 202-208).

The study compared indoor air levels of respirable suspended particulates (RSP) and nicotine under three conditions: (1) smokers smoke inside the home; (2) smokers only smoke outside the home; and (3) no smoking at all. With smokers smoking inside the home, the average nicotine level inside the home was 1.4 ug/m3. With no smoking at all, the average nicotine level was below 0.2 ug/m3. With smokers smoking outside the home only, the average nicotine level was 0.55 ug/m3.

In response to the study, Action on Smoking and Health (ASH) is promoting policies by which employers fire all existing smokers or refuse to hire smokers, even if they smoke only outside of work, in order to protect nonsmoking employees from the toxic breath of the smoking employees. ASH is also arguing that smokers should not be allowed to adopt children, even if they agree to smoke only outside of the home, because their breath will expose children to unsafe levels of tobacco smoke. Moreover, ASH argues that before children whose parents are separated visit a parent who smokes, that parent should be required to change clothes and rinse with mouthwash.

ASH states: "This study suggests that society must go beyond merely protecting children from being in the presence of parents and others who smoke in their homes, and think about more effective measures to protect children from parents who smoke anywhere." ...

"It also provides a strong scientific basis for agencies which already refuse to permit smokers to adopt children, even if the potential adoptees claim that they only smoke outdoors, and never in the presence of the child." ...

"Judges in almost three-fourths of the states have issued orders prohibiting smoking in homes to protect children involved in custody disputes. But this study would permit the parent who obtained the order to go back and strengthen it, perhaps requiring the smoking parent to change clothing and use a mouthwash before the child visits, predicts attorney Banzhaf, who has helped nonsmokers obtain some of these court orders." ...

"We've always known that a smoker's breath stinks. Now we know that it also creates indoor air pollution which can harm children and perhaps some adults."

The Rest of the Story

The rest of the story is that there is a fatal flaw in the study which invalidates the conclusion: it is highly likely that some smokers who claimed only to smoke outside the home actually do smoke in the home, at least on occasion. This would have completely explained the study result: that levels of smoke in homes with smokers who claim to only smoke outdoors are intermediate between levels in a smoke-free home and levels in a home with smokers who admit smoking inside the home.

It is likely that some smokers are not being honest about smoking inside the home because very clearly there is a social pressure not to smoke in the home. With all of the publicity - much of it due to ASH itself - about how smoking around kids is child abuse and how smokers are child abusers, it is not surprising that smokers would be hesitant to admit that they do smoke indoors with children present. Thus, the hypothesis that smoke smokers are not being honest about smoking inside the home is quite plausible.

Importantly, this hypothesis would completely explain the observed findings. Not all smokers are being dishonest, just a proportion of them. Thus, the smoke levels among those who claim to smoke only outdoors would be intermediate between levels in smoke-free homes and levels in homes where the smoker admits to smoking indoors. This alternative hypothesis is entirely consistent with the observed findings of this study. Thus, unless the authors can disprove this hypothesis or show why it is implausible or unreasonable, the study conclusion is not valid.

The authors, however, do not provide any evidence as to why this hypothesis is not plausible. In fact, they reject this hypothesis without a word of explanation. They point out that the results could be due to a true effect of outside smoking on smoke levels in a home or to smokers not telling the truth and then they simply conclude that the former is the correct explanation. But they provide no evidence or even reasoning to suggest why the latter explanation is unlikely to be correct.

I find this to be a striking bias in the article (not atypical of the bias I am seeing these days in many articles in the tobacco control literature). You have two possible explanations for the study findings. Rather than objectively evaluating the evidence to decide which hypothesis is likely to be correct, you instead simply reject the least favorable explanation. That is essentially what is going on here.

Of note, only 4 of the 39 households in which there was a smoker reported that smoking occurred inside the home. On its face, this seems too good to be true and it should have alerted the investigators to the likely possibility that they were not obtaining accurate information about the smoking locations in that household.

This study is plagued by a fatal limitation: it is unable to objectively determine whether smoking occurred in the home or not. Normally, one might not make too much of such a limitation. But because the primary purpose of the study was to determine whether outdoor smoking can result in indoor exposure, it is inexcusable not to develop a means to validate the actual locations where smoking occurred in these households. Or, alternatively, to admit in the study discussion that dishonesty about smoking locations could be an alternative explanation for the study results.

There are four important implications to this story.

First, it makes it clear that this study cannot be used as evidence that outdoor smoking results in substantial secondhand smoke exposure for children inside the home. Action on Smoking and Health has either not taken the care to analyze the validity of the study or else it is so excited about the opportunity to further lambast smokers that it ignored the lack of validity of the study findings.

Second, it reveals the increasing investigator bias in tobacco control articles these days. This is a disturbing trend to me. It suggests that the peer review system is not working particularly well for tobacco control. I think perhaps part of the problem is that the articles are being send to the same cadre of reviewers, all of whom are sharing the same bias towards favorable results.

Third, it has unfortunate implications for children. If tobacco control groups follow ASH's lead and tell the public that smoking outside is of little help to protect kids, then many smokers may well decide that it is not worth taking the trouble to smoke outside and the exposure of children may increase, rather than decrease.

Fourth, and most disturbingly, the misinterpretation of this study's results may lead to efforts to bar smokers from the workplace and to prevent smokers from adopting children, both of which would be tragic mistakes.

In a press release defending its position that employers should consider firing smokers and refusing to hire smokers, Action on Smoking and Health (ASH) argued that allowing employers to discriminate against smokers in employment is acceptable because nobody has the right to any particular job and that employees who want a job must accept the conditions of employment.

According to the press release: "Smoking, whether on or off the job, causes the same ballooning of health care costs, disability payments, days of sick leave, and other costs to the employer. Nobody has the right to any particular job. Under our free enterprise system, employers -- rather than bureaucrats -- determine the conditions of employment, and employees who want a job must accept the conditions. The only major exception is that basing decisions on factors like race, national origin, gender, disability, etc. are prohibited since these are fixed conditions and don't adversely affect the employer. Smoking is an activity rather than an immutable condition, and each smoking worker seriously affects the employer's bottom line."

Action on Smoking and Health's executive director - Attorney John Banzhaf - appeared on a Fox Morning Newsshow and promoted the idea of employers firing their smoking workers. The press release was issued to promote Banzhaf's appearance and remarks on the show.

The Rest of the Story

If one accepts ASH's argument that employers determine the conditions of employment, that employees who want a job must accept the conditions, that the only major exception is discrimination on the basis of race, gender, etc., and that nobody has a right to any particular job, then it becomes difficult to argue the need for restaurant smoking bans.

Why should the government intervene to ban smoking in all restaurants if the conditions of employment are up to the employer, who must accept those conditions? If people do not have a right to hold any particular job, then why can't they just find a new job if they don't like their working conditions, such as smoking in their working environments?

Because ASH has gone to such an extent to defend its promotion of smoker-free workplace policies, it seems to me that it has just crafted an argument against restaurant smoking bans, thus shooting itself in its own foot (since ASH is a major proponent of workplace smoking bans).

Of course I still support workplace smoking bans because I don't accept ASH's argument that employees must accept the conditions of their employment. I do not believe that workers can or should have to simply find another job if they do not want to be exposed to an easily preventable occupational health hazard at their work site.

But the point here is not whether restaurant smoking bans are justified, but instead, just how ridiculous ASH's argument is in light of its own support for workplace smoking bans. This story reveals how deep ASH is digging to defend its promotion of a policy that just doesn't mesh with its overall approach to tobacco control. It is inconsistent to argue that employers can and should set the conditions of employment - including not hiring smokers - but that the employers cannot determine the smoking conditions in their own establishments.

Anti-smoking groups need to re-examine the inconsistency in their arguments in support of smoker-free workplace policies and they need to square their position on this issue with their position on smoke-free workplace policies. And the only way to do this is either to drop their support of the latter or to drop their support of the former. I obviously think that dropping their support of smoker-free workplace policies is the appropriate thing to do.

ASH apparently supports not only policies by which employers fire their smoking employees, but also policies by which employers fire employees whose spouses smoke. That is completely absurd. It is going way too far and it represents an undue invasion of employee privacy.

Someone needs to stop ASH before its fanaticism actually starts to influence policy. The only one who could do it is another group within the tobacco control movement. However, I doubt any group - even one which opposes the extreme policies being promoted by ASH - will be willing to criticize a fellow tobacco control group. As I've learned, that's just not allowed.

Monday, June 23, 2008

As I discussed here last week, three anti-smoking and health groups in England endorsed a recent study - reported by the media - showing as much as a 40% decline in heart attacks in some hospital districts following the implementation of a nationwide smoking ban. These groups told the public that this study supports the conclusion that the observed decline in heart attacks was due to the smoking ban. Based on the study, one group even called the ban "the most significant public health initiative this century."

The Rest of the Story

Data on trends in hospital heart attack admissions in England posted by Colin Grainger on his Freedom to Chooseweb site do not support the anti-smoking groups' claims. These data show that there is wide random variation in heart attack admissions in England, with swings of up to 5.4% from year to year. From 2002-2003 to 2003-2004, heart attack admissions fell by 2.4% in the absence of a smoking ban. Clearly, one cannot take the observed change of about 3% in the first nine months following the smoking ban and attribute it to the smoking ban. It could easily represent random variation in the data. In addition, since heart attack admissions have declined the past two years, it is also possible that the observed decline simply reflects a secular trend of declining heart disease morbidity.

Moreover, since these data represent only nine months of the year, it is possible that after a full year's data are available, the decline in heart attack admissions will not be as great as it now appears. But even if the decline is truly 3%, there is no way to conclude that such a small change is due to the smoking ban, as opposed to random variation and/or secular changes in heart attacks that would have occurred anyway, even without the smoking ban.

Since anti-smoking groups in the U.S. and elsewhere are arguing that smoking bans cause immediate, dramatic declines in heart attacks - on the order of 15% to 40% - it would seem that these data from England actually invalidate the conclusions from these prior studies. It is amazing to me how the anti-smoking groups can twist and distort the data to support a conclusion that this study is consistent with these prior results that show a dramatic decline in heart attacks following smoking bans.

The problem with the anti-smoking groups spinning the data in this way is that it exposes them. If they are going to conclude that smoking bans have a dramatic effect on heart attacks no matter what the data show, then their conclusions are obviously not based on science, but purely on ideology. The agenda is dictating their "scientific" conclusions, rather than their science dictating their public statements. Unfortunately, they appear to have things backwards. The science is supposed to guide the agenda, not the reverse.

Wednesday, June 18, 2008

The media is widely reporting that there has been a drop in heart attack admissions of up to 40% in England due to the implementation of the national smoking ban last July (report 1; report 2; report 3).

According to these three articles, the smoking ban resulted in a decline of up to 40% in hospital heart attack admissions during the first nine months that the ban was in place. The articles report that overall, the number of heart attack patients being admitted has fallen in more than half of England's hospital trusts. Specifically, there was a decline in heart attack admissions in 66 of the 114 trusts examined.

The total number of heart attack admissions during the nine-month period following implementation of the smoking ban was 1,384 less than during the same nine-month period a year earlier. One hospital trust saw a 41% decline in heart attack admissions.

Three anti-smoking or health groups - the British Heart Foundation, the British Cardiovascular Society, and Action on Smoking and Health - were quoted in these articles as concluding that the observed decline in heart attacks was attributable to the smoking ban.

According to the articles:

"The British Heart Foundation said that it showed the ban was the 'most significant public health initiative this century'".

"Amanda Sandford, of the pressure group Action on Smoking and Health, added: 'This is excellent news. It seems likely that the drop in hospital admissions for heart attacks is linked to the implementation of the smoking ban. It shows just how quickly the benefits can be felt. Even if the overall percentage reduction appears small, the fact that this amounts to over a thousand people whose lives have been saved is extremely important.'"

"Dr. Nicholas Boon, president of the British Cardiovascular Society, said: 'This is great news. It is exactly what we hoped and expected to see. When you place these figures with the research in Scotland, Ireland, France and Rome, it is consistent with the observation that the ban has been followed by significant improvements in heart attack rates. It is early days, but the benefits may be greater in the long run.'"

The Rest of the Story

This is pure junk science, and it is a shame that the anti-smoking and health groups are willing to stoop down to the level of junk science to promote their agendas.

The fact that heart attacks have declined in more than half of the hospital trusts is of no consequence at all with respect to the hypothesis that the smoking ban led to a reduction in heart attack admissions. Even if one assumes that there is no secular change occurring in heart attacks, under the null hypothesis - that the smoking ban had no effect on heart attacks - one would expect that heart attacks would decline in one-half of the hospital trusts. That is, if smoking bans have no effect on heart attacks, then one would expect that heart attacks would decline in 57 of the 114 hospital trusts. The fact that heart attacks declined in just 66 of the hospital trusts is actually pretty strong evidence that the smoking ban did not cause a decline in heart attacks.

In fact, we can quantify the probability that if smoking bans have no effect on heart attacks, one would observe a decline in heart attacks in 57 of 114 hospital trusts. It turns out that this probability is greater than 5%, the level generally considered statistically significant. Thus, the reported finding is not significantly different than one would expect by chance alone.

The actual 95% confidence interval on the reported proportion of hospital trusts that saw a decline in heart attacks is 48.8% to 67.0%. Since this confidence interval includes 50%, one cannot conclude that the proportion of hospitals that saw a decline in heart attacks is different from what would have been observed by chance alone (if there were no effect of smoking bans on heart attack admissions). Thus, these data provide no evidence of any effect of the smoking ban on heart attack admissions.

Moreover, the overall reported decline in heart attacks is only 3%. This is such a small effect that there is no way to attribute the decline to the smoking ban.

Furthermore, it is well-documented that heart attack rates in Europe have been declining over time in recent years. It is unlikely that the 3% observed decline in heart attacks is significantly higher than the decline that would have occurred anyway due to secular trends. Without any analysis of the trends in heart attack admissions over time, it is impossible to draw the conclusion that the 3% decline was due to the smoking ban, rather than merely reflective of a secular trend.

Even worse, there is no control group in the study. Even if the 3% decline in heart attacks in England were significant, without a control or comparison groups, it is impossible to know that the decline is greater than what would have been expected in the absence of the smoking ban.

It appears that the sloppy science being promulgated by anti-smoking groups and researchers in the area of the evaluation of the effects of smoking bans on heart attacks has become so pervasive that it has infiltrated into the media itself. Now the media are conducting their own shoddy analyses and representing them as having some meaning.

Let me assure my readers that this particular analysis is meaningless. If anything, the data best support the conclusion that the smoking ban had no substantial effect on heart attack admissions. A 40% decline in admissions in Helena was attributed to the smoking ban by anti-smoking researchers. as was a 27% decline in Pueblo. Even if the observed decline in smoking was due to the smoking ban rather than a secular change or random variation, the finding of just a 3% decline would wipe out the conclusion that smoking bans have a dramatic effect on heart attack admissions.

What is disturbing to me is not that the media would put forth such a shoddy scientific analysis and unsupportable conclusion. What disturbs me is that anti-smoking groups find this shoddy science to be convincing. They are so biased in their views that they apparently care only about the direction of the results, not the scientific validity of the findings.

This is a sad state of affairs for the tobacco control movement, because it means that we are continuing to lose our scientific integrity. The political cause has become more important than the science.

Unfortunately, this makes us no better than the tobacco companies that we have consistently criticized for their own shoddy science. And maybe even worse, because the tobacco companies have at least made some changes in their representation of science to the public. They are at least moving somewhat in the right direction. But we are apparently moving in the wrong direction.

We need to take the high road and to protect the scientific integrity of our movement. In the long run, it does no good to stoop to the level of junk science to support our agenda. It puts us on the road to the eventual loss of credibility and of the public's trust.

Tuesday, June 17, 2008

In a sign of the continuing disappointment of the tobacco control community over the many loopholes and weaknesses that are present in the FDA legislation because the Campaign for Tobacco-Free Kids sold out the public's health to obtain the support of Philip Morris, another tobacco control group has today announced its opposition to the legislation and issued an action alert urging its members to vigorously oppose the bill.

In an action alert sent out today, Arizonans for Nonsmokers' Rights (ANSR) expressed opposition to the legislation and urged its constituents to write to the entire Arizona Congressional delegation in opposition to the bill.

Among the many concerns expressed by ANSR were the fact that the FDA is already under-funded and over-extended and has enough trouble just regulating the nation's prescription drug supply. In addition, ANSR is concerned about a possible chilling effect that the legislation might have on state and local tobacco control efforts. Furthermore, ANSR opposes the bill's menthol exemption, which it says is proof of Philip Morris' influence on the legislation.

The action alert concludes: "S.625/H.R.1108 is seriously flawed and must be defeated. It has already passed committees in both the House and Senate. Phone calls and letters are needed immediately urging Senators and Representatives to vote "No" on S.625/H.R.1108."

The Rest of the Story

The coalition of support for the FDA tobacco legislation continues to crumble as the truth about the legislation is gradually revealed to the public. It is quite clear that the tobacco control community does not support the crafting of a piece of tobacco control legislation by negotiating with Philip Morris to see what the nation's leading tobacco company is willing to support. As groups are becoming aware that the Campaign for Tobacco-Free Kids negotiated this legislation with Philip Morris and made numerous concessions to protect Big Tobacco profits, they are gradually withdrawing their support for the bill and moving over to the opposition side.

This is what happens when one organization presents itself as the sole representative of the tobacco control community and takes it upon itself to sit down at the negotiating table with Philip Morris to hammer out legislation that the nation's leading cigarette company can support. Essentially, what the Campaign for Tobacco-Free Kids has done is to hammer this legislation down the throats of the entire tobacco control community. While it has taken a long time for the groups to come to this realization, it is now happening rapidly and these groups are not taking it any longer.

I congratulate ANSR for having the courage, insight, skilled policy analysis, and principle to take the high road and oppose this legislation, which provides special protection to Big Tobacco and institutionalizes tobacco use and the defrauding of American consumers by the government itself.

I know that many more local tobacco control groups feel the same way and it is only a matter of time before they join ANSR, NAATPN, AAPHP, and other groups which stand against Philip Morris and its allies at the Campaign for Tobacco-Free Kids and the American Medical Association.

The American Medical Association (AMA) today announced that despite the protests of African-American tobacco control groups, prominent public health leaders, and many of its own physician members, it would oppose the removal of the menthol exemption in the FDA tobacco legislation in order to protect tobacco sales and thus retain the support of Philip Morris for the bill.

According to an Associated Press article, the reason for this opposition to the removal of the menthol exemption "is that the menthol exemption helped congressional leaders reach a bipartisan compromise on legislation that would put cigarettes under government regulation." In other words, it was the menthol exemption that was deemed necessary to retain Philip Morris' support for the legislation.

However: "William S. Robinson, executive director of the African American Tobacco Prevention Network, said the group believes a superior tobacco control bill could be crafted without the support of Philip Morris, which makes several menthol brands. 'We understand from an industry perspective why menthol is off the table,' Robinson said. 'We think part of it is because menthol represents almost 30 percent of the $70 billion U.S. cigarette market.'"

The AMA president - Dr. Ron Davis - was described in the article as supporting the menthol exemption because unlike other cigarette additives, menthol does not lure young smokers: "And while other flavor additives are aimed at luring young smokers, menthol is different, he said. Banning it would merely drive mature black smokers to other brands, said Davis. 'It would change the entire political dynamic.'"

The Rest of the Story

It is greatly disappointing to me that the American Medical Association would sell out the health of the nation's African-American youths and adults to protect cigarette sales in order to keep the nation's leading cigarette company happy and remaining shoulder-to-shoulder with the health groups.

What the AMA is doing here is supporting the protection of cigarette company profits instead of protecting the public's health.

Moreover, the AMA is using lame and unsupportable excuses to defend its tobacco industry-supporting position. To argue that menthol is unlike other cigarette additives in that it is not intended to support the smoking uptake process is unsupportable by the scientific evidence. In fact, the evidence documents that menthol is the most - not the least - effective flavoring in cigarettes, and that unlike cigarettes with other flavorings banned by the bill, which almost no one smokes, menthol cigarettes are actually being used by millions of Americans.

The AMA is supporting a ban on flavorings that are not actually used to any significant degree to hook kids, but opposing a ban on the one flavoring that we know contributes to the addiction of youth smokers and which literally millions of Americans are using. That makes absolutely no public health sense.

The AMA sounds more like a tobacco company than a group of doctors when it argues that banning menthol would merely lead smokers to switch brands and would have no effect on smoking initiation or cessation. There is actually strong reason to believe that a ban on menthol could have a substantial effect on both smoking initiation and smoking cessation. The AMA clearly has no evidence to support its position. This is merely a lame excuse being used to defend what is obviously a purely political action: a sell out designed to protect the deal forged between the Campaign for Tobacco-Free Kids and Philip Morris.

The AMA has now joined the Campaign for Tobacco-Free Kids in selling out the health of African-Americans to protect tobacco company profits.

Thursday, June 12, 2008

With the imminent death of the proposed FDA tobacco legislation and the revelation that this bill resulted from a negotiation between the Campaign for Tobacco-Free Kids and Philip Morris in which the Campaign appointed itself as the sole representative of the tobacco control movement and sold out the public's health for the protection of tobacco industry profits, I believe it is time for the tobacco control movement to abandon the current legislation and go back to the drawing board.

This time, there needs to be an inclusive process in which the entire community is involved in the development of the legislation. It should not be developed by just one group at a negotiating table with a tobacco company.

The discussion should begin by dropping the mistaken notion that the best approach to dealing with the tobacco problem is to give the FDA limited regulatory authority over tobacco products. The idea that the FDA can come up with regulations that would make cigarettes substantially safer is not only absurd, but it is not science-based. There is absolutely no evidence to support such an approach to tobacco control. It is only if we drop our obsession with FDA regulation that I think we can actually develop an effective national strategy to combat the tobacco problem.

In the spirit of putting something on the table which could serve as a basis for further discussion, I present here what I think would be the most effective and meaningful legislation to address the problem of tobacco use.

The Rest of the Story

The basis for an effective tobacco control strategy should be a focus not on the supply side, but on the demand side. Cigarettes are an irredeemably unsafe product and there is no science to support the idea that cigarettes could ever be made safely. Moreover, there is no evidence that interventions that focus on cigarette supply have ever been successful.

In contrast, all of the proven, effective tobacco control interventions have focused on reducing cigarette demand. This is where we should be placing our energy and our resources.

The centerpiece of a national tobacco control strategy should be the single most effective intervention to reduce smoking: a state-of-the-art mass media campaign to educate the public, increase awareness of the important issues, discourage smoking initiation, and encourage smoking cessation.

The American Legacy Foundation has run such an effective campaign - the "truth" campaign. However, due to a dramatic decline in funding, this campaign can no longer have the same kind of impact. An effective national tobacco control strategy would provide a steady stream of funding for a sustained, aggressive, national anti-tobacco media campaign.

While a number of states - such as California and Massachusetts - have run their own highly successful anti-smoking media campaigns, sustaining funding for these programs has been a challenge and the overwhelming majority of states do not have such media campaigns. The second major component of an effective national tobacco control bill - in addition to a national anti-smoking media campaign - would be provision of sustained funding for aggressive anti-smoking media campaigns in all 50 states.

In fact, the coordination of campaigns at the national and state/local levels is an important part of an effective tobacco control strategy. An effective bill, therefore, would provide for sustained funding of tobacco control campaigns - including those using the mass media - at the national level and in every state.

The development and coordination of the national anti-tobacco campaign could either be placed in the hands of a newly created federal tobacco control agency, an existing agency (the Office on Smoking and Health at CDC), or a non-government foundation (such as the American Legacy Foundation). Similarly, the statewide anti-tobacco campaigns could be coordinated at the level of state health departments or by existing or newly-created independent state tobacco control foundations.

Where would the funding come from to support this unprecedented level of tobacco control intervention? The answer is simple: from penalties to tobacco companies that are based on the number of youth smokers who smoke their cigarette brands. It is very easy to determine the number of youths who are smoking and the brands that they are smoking. Based on this information, we could assess penalties to tobacco companies that are based on the market share of their brands among underage smokers.

This funding strategy makes sense for several reasons.

First, it would create a true financial incentive for the tobacco companies not to market their products to youths. In fact, the "target" levels of youth smoking prevalence that would be allowable before penalties are assessed could be gradually reduced over time in an attempt to produce a gradual reduction in youth smoking prevalence.

Second, there is little that the tobacco companies could say in opposition to such a proposal. This would test whether they are truly sincere about their goal of reducing youth smoking. If they are sincere, then they should have no problem developing their own effective campaigns to reduce youth smoking, or at least, to curtail their aggressive marketing practices aimed at underage smokers.

Third, there is no concern about making the anti-smoking funding dependent upon sustained youth smoking. As youth smoking declines, it is true that funding would also decline. However, less funding would be needed. As long as the youth smoking prevalence targets were being met, the goals of the program would be met. Less funding would be needed if fewer smokers needed to be reached. In fact, the ultimate goal of the program would be to reduce the need for the program itself. If smoking rates declined substantially and less revenue were available, that would not be a problem - that would be the goal.

There do exist several pieces of legislation that could serve as the basis for developing this idea. The idea of youth smoking targets was proposed in the McCain bill that ultimately failed in 1997. The idea of gradually reduced smoking prevalence targets with penalties to tobacco companies that would pay for national and state anti-smoking campaigns was proposed by Senator Enzi in legislation he filed this year as an alternative to the FDA tobacco legislation.

Senator Enzi's bill could well serve as the basis for the development of the legislation I propose. The major changes necessary from his proposal would be: (1) relying upon youth smoking prevalence, rather than overall smoking prevalence, to derive the tobacco company penalties; (2) ensuring that all 50 states be allotted funding for anti-smoking campaigns; and (3) placing a clear and unequivocal focus on mass media anti-smoking interventions, rather than youth access, school-based, or other ineffective programs.

The greatest strength of this proposal over the FDA legislation is that it is evidence-based. It is based on very solid science which documents that anti-smoking campaigns - especially those employing state-of-the-art mass media techniques - are the single most effective intervention available to reduce tobacco use.

Unlike the Campaign for Tobacco-Free Kids, which has no evidence to support its contention that the FDA legislation would save "countless" lives, I can provide solid evidence to support my assertion that this proposal would save lives (we could even use the results of published research to count them).

In essence, this is a self-regulating system for the reduction of youth smoking by targeted amounts. If the youth smoking rates do not decline as rapidly as outlined, then more money goes into aggressive anti-smoking programs, which will reduce youth smoking. If the youth smoking rates fall as outlined, then less money will go into anti-smoking programs, but the youth smoking reduction targets will have been met.

I believe that this is a strategy around which all tobacco control groups could rally. It would energize and mobilize the entire movement. It would bring an unprecedented amount of new and sustained funding for tobacco control activities at the national and state levels.

In addition, I believe this is a policy that would have a reasonable chance of Congressional support. Senator Enzi has already thrown his weight behind the proposal, and he is one of the opponents of the current FDA bill.

There is tremendous room for discussion among tobacco control advocates about how the details of such legislation would be worked out. Every organization and advocate could play a role in doing this. Everyone would have a place at the table. There could be inclusion of advocates representing minority groups and special attention to making sure that the interventions supported by the program would be culturally appropriate and targeted, in good part, to communities of color and other disadvantaged or under-served groups.

In contrast to the FDA legislation, which has divided and torn the tobacco control community apart, this proposal would bring the entire movement together and allow much-needed healing to occur.

And unlike the process that led to the FDA legislation, which was and remains secretive because of the Campaign for Tobacco-Free Kids' need to hide the truth, this process could be truly transparent and inclusive.

Finally, unlike the FDA legislation, which had to sell out the public's health for financial security for Big Tobacco because the Campaign needed to keep Philip Morris on board, this legislation would not depend upon tobacco industry support. It is simple and straightforward enough that it would serve as a test of whether a legislator truly stands up to Big Tobacco or not. The current FDA legislation is not such a test because those who support the legislation are actually standing with Philip Morris and those who oppose the legislation can do so on the grounds that they are standing against Philip Morris.

Wednesday, June 11, 2008

Last Friday, the Campaign for Tobacco-Free Kids released the results of yet another poll which purportedly shows that the public supports the FDA tobacco legislation that is currently before Congress. The Campaign wrote: "A new national poll released today finds that voters strongly support legislation to grant the U.S. Food and Drug Administration (FDA) authority over tobacco products and also believe it would be an important accomplishment for Congress. The poll finds that 70 percent of voters support Congress passing the legislation and 73 percent believe passage of the legislation would be an important accomplishment."

The Campaign writes that: "Support for FDA regulation of tobacco climbs even higher (81 percent) when voters hear specific provisions of the bill."

The provisions that respondents were informed about include:

"restricting tobacco sales to children by requiring ID checks for younger buyers and fining retailers who sell tobacco to minors";

"restricting tobacco marketing aimed at children such as limiting advertising in magazines with a large percentage of readers under age 18";

"requiring tobacco companies to take measures, when scientifically possible, to make cigarettes less harmful";

"preventing tobacco companies from making claims that some products are less harmful than others unless the FDA determines those claims are true"; and

"requiring the reduction or removal of harmful ingredients, including nicotine, from tobacco products".

The Rest of the Story

This is another example of complete junk science from the Campaign for Tobacco-Free Kids to promote the now-doomed FDA tobacco legislation.

While these results demonstrate that there is general support for the idea of the FDA regulating tobacco products, this poll in no way demonstrates that the public supports the actual legislation that has been negotiated by the Campaign for Tobacco-Free Kids and Philip Morris.

The Campaign boasts that support for the bill rises dramatically when respondents are told about the specific provisions of the bill. However, the Campaign failed to ask any questions in which they assessed respondents' opinion of the bill with regards to the following specific provisions:

exempting menthol from the list of banned flavorings that can be added to cigarettes;

precluding the FDA from increasing the legal age of purchase for cigarettes;

precluding the FDA from regulating the sale of tobacco products at any particular type of retail outlets;

allowing Congress to overturn any major FDA regulations with a simple majority vote and a streamlined legislative process;

disallowing the FDA to require a prescription-only access system for cigarettes;

precluding the FDA from eliminating nicotine in cigarettes; and

allowing the tobacco industry to sit on the expert advisory panel to the FDA.

Had they asked those questions, the Campaign would certainly have obtained a very different picture regarding the public's support for this particular legislation.

In addition, the Campaign failed to assess the public's support of the bill after being informed that the legislation is the result of a negotiation with Philip Morris and that it contains numerous loopholes inserted to appease Philip Morris and protect the financial interests of the leading tobacco company.

If the Campaign were truly interested in understanding the public's opinion of this legislation, it would have asked the all-important question:

Would you favor or oppose the U.S. Congress passing a bill that would give the FDA the authority to regulate tobacco products, if you knew that Philip Morris - the nation's leading tobacco company - were in strong support of the legislation?

I doubt that the Campaign would be able to muster up even 20% support for the legislation if it were actually telling the public the truth.

This is truly junk science because it is hiding the truth from people and assessing their opinion on a hypothetical issue, but without actually measuring opinion on the actual issue at hand - the specific legislation itself.

In fact, I hesitate to call this "junk science" because it may give "junk science" a worse name than it deserves. This isn't junk science. This really isn't science at all.

Tuesday, June 10, 2008

A study published in this week's issue of the Archives of Internal Medicine concludes that smoking causes memory loss among middle-aged adults (see: Sabia S, Marmot M, Dufouil C, Singh-Manoux A. Smoking history and cognitive function in middle age from the Whitehall II study. Archives of Internal Medicine 2008; 168:1165-1173).

Data came from the Whitehall II study of over 5,000 British civil servants who were interviewed at baseline in 1985-88 and followed prospectively for approximately 12-17 years. Cognitive function, including memory, reasoning, vocabulary, and semantic and phonetic fluency was assessed in middle-age, when most of the participants were between the ages of 47 and 72.

Compared to never smokers, current smokers were significantly more likely to have memory impairment (odds ratio = 1.5) at follow-up. This effect remained (odds ratio = 1.4) significant after controlling for other health behaviors and health measures.

Before controlling for other health behaviors and health measures, current smoking was associated with a significant decrement in reasoning, vocabulary, and phonemic and semantic fluency. However, all of these effects disappeared after controlling for the other health behaviors and health measures (which included socioeconomic status, education, marital status, physical activity, nutrition, alcohol use, and other medical problems, such as stroke, high blood pressure, heart disease, high cholesterol and diabetes).

Long-term ex-smokers were found to have significantly increased memory (odds ratio = 0.8), as well as significantly increased vocabulary, phonemic fluency, and semantic fluency, even after controlling for other health behaviors and health conditions.

The study concludes that "smoking in middle age is associated with memory deficit" and that "long-term ex-smokers are less likely to have cognitive deficits in memory, vocabulary, and verbal fluency."

In a Health Day news article about the study, the lead author was quoted as concluding: "Our results suggest that smoking had an adverse effect on cognitive function."

In addition, a scientific consultant to the American Lung Association was quoted as stating that the study either shows that smoking makes people stupid or that stupid people choose to smoke. According to the article: "Dr. Norman H. Edelman, scientific consultant to the American Lung Association, said: 'This study is generally a confirmation of previous work. But there is a fundamental question: Are they stupid because they smoke or do they smoke because they are stupid?'"

The Rest of the Story

Before concluding that this study demonstrates an effect of smoking on memory in middle age, I think it is important to consider two major limitations of the study.

First, the study finds significant impairment of other cognitive functions in current smokers - reasoning, vocabulary, and verbal fluency - which disappears after controlling for other health behaviors and health conditions. This demonstrates that there is substantial confounding in the study. Although the results for memory remained significant after controlling for the other variables in the model, the presence of strong confounding suggests that there may be other factors, not measured in the study, which could explain the relationship between smoking and lower memory function scores.

The second limitation, which is more troubling, is the study's finding that ex-smokers actually performed better in memory, vocabulary, and verbal fluency tests. Clearly, one would not conclude that smoking for a short period of time increases cognitive ability in these areas. Instead, what these results demonstrate is that there is a strong selection effect present in these data. Those smokers who make a decision to quit and do so successfully represent a very different population from smokers who continue to smoke. And the factors which separate these two populations are associated with precisely the outcome variables measured in the study: cognitive function.

The authors are quick to dismiss their finding that ex-smokers had better cognitive function by arguing that they must have had other health behaviors that led to better cognitive function. The idea that the smoking caused the increased cognitive function is not entertained. However, for the finding that current smokers had impaired memory, the study does not similarly dismiss the finding by arguing that they must have also had other health behaviors that led to worse cognitive functioning.

The problem is that this is a very biased interpretation of these data. If one is going to invoke other unmeasured behavioral factors to explain the positive findings for ex-smokers, then one must also be willing to entertain the hypothesis that these unmeasured factors also explain the negative findings for current smokers.

Once one acknowledges that there are unmeasured factors which are affecting the study results, I don't think one can conclude that those unmeasured factors are only affecting the positive results for ex-smokers, but not the negative results for current smokers.

In fact, what I believe is going on here is most likely a selection effect. What the study is doing is examining two different populations of ever smokers: one which makes the decision to quit and does so successfully and the other which either decides not to quit or tries to quit unsuccessfully. These populations are quite different and most importantly, they are likely to differ on precisely the variables that would be expected to affect cognitive function. The reported results for long-term ex-smokers confirm this hypothesis. Because this is a plausible alternative explanation for the study findings regarding the observed impairment in memory among current smokers, the validity of the study's conclusion is thrown into question.

That ends the epidemiology portion of this commentary. But I cannot conclude without saying something about Dr. Edelman's comment that these results either show that smoking makes people stupid or that it is stupid people who decide to smoke.

First of all, even if the study conclusion is valid, it does not demonstrate that smoking makes people stupid. Having a measurable decline in memory functioning does not equate to being "stupid." Using such a term is not only unscientific and inaccurate, but it is degrading to smokers and frankly, offensive.

Second, the study does not show that it is stupid people who start to smoke. What it likely shows is that those who continue to smoke have other behavioral or other factors that are associated with deficits in memory. This doesn't mean that those people are stupid. We do know that smoking is associated with lower levels of education, in general. But again, that doesn't equate to people being "stupid." Once again, I find Dr. Edelman's comment to be unscientific, inaccurate, degrading, and offensive.

Monday, June 09, 2008

Action on Smoking on Health (ASH) has again called for malpractice lawsuits against physicians who fail to follow the new Public Health Service (PHS) clinical practice guideline for smoking cessation, which recommends that every smoking patient be prescribed nicotine replacement therapy or other pharmaceuticals to aid them in quitting smoking.

In a press release issued last month, ASH writes: "New federal guidelines issued Wednesday for doctors treating smokers could trigger a wave of wrongful death medical malpractice legal actions, suggests Action on Smoking and Health (ASH), which serves as the legal action arm of the antismoking community. Indeed, says ASH, there are over 40,000 potential plaintiffs yearly. The guidelines require physicians not only to thoroughly warn smoking patients about the dangers of smoking, but also mandate that the clinicians provide one or more of the treatments which have been proven effective in helping people quit. Yet most physicians reportedly fail to do this, and as a direct result a major study shows, more than 40,000 smokers die needlessly. ASH notes that hundreds of thousands more become disabled annually, and could also bring malpractice actions."

"Thus, if a doctor in violation of the guidelines failed to provide effective treatment for a smoker, and the smoker subsequently died of a heart attack or other condition - or or become incapacitated by a condition - which was proximately caused by his smoking, the estate could sue the physician for medical malpractice, claiming that the guidelines establish the appropriate standard of care which the physician deliberately breached." ...

"'Since physician malpractice kills over 40,000 smokers annually - more than motor vehicle or product liability accidents - it should not be surprising if antismoking lawyers, as well as those in private practice working on contingency fees, find physicians who deliberately flout federal guidelines to be a new major target of litigation,' suggests Banzhaf."

The Rest of the Story

There are four essential showings in a medical malpractice case. The plaintiff must show that there exists: (1) a legal duty owed to the plaintiff by the defendant; (2) a breach of that duty; (3) a causal relationship between the breach of duty and the incurred injury; and (4) damages."

The primary reason why ASH's suggestion that failure of physicians to prescribe smoking cessation drugs for their smoking patients represents malpractice is incorrect is that ASH fails to provide any reasonable argument for how the 3rd showing in a medical malpractice case - that there is a causal relationship between the breach of duty and the incurred injury - could possibly be met in a smoking malpractice case. This would require proving to the jury that the physician's failure to warn the patient to quit smoking was the cause of the injury sustained by the patient.

This would imply that 2 things would have to be shown: (1) that the patient would have quit smoking if only the physician had advised them to quit and followed the PHS guidelines; and (2) that the reason the patient did not quit smoking was that the physician failed to advise them to quit and failed to follow the PHS guidelines.

This seems an unreasonable, if not impossible, point to prove. How can we possibly know that a patient would have successfully quit smoking if only the physician had followed the guidelines? The overwhelming scientific evidence supports a conclusion that the patient would most likely NOT have quit smoking, even if the physician had followed the guidelines. The data demonstrate that the cessation success rate, even with physician treatment, is dismal. The success rate does not even come close to approaching 50%; thus, it is more likely than not that even with physician advice to quit smoking, the patient would not have been successful in quitting smoking.

The success rates reported in the guideline itself are generally below 20%. This means that it is much more likely than not (in fact 4 times out of 5) that a patient who goes through the suggested intervention will fail to quit smoking.

I view this as an intractable problem in the use of the PHS clinical practice guideline in medical malpractice lawsuits for failure to properly treat tobacco dependence. Until such time as there is a truly effective treatment for smoking cessation (one that works most of the time), there really can be no basis for establishing a causal relationship between the breach of duty and the incurred injury.

In addition, I think it would be impossible to demonstrate that the physician owes a legal duty to the patient in the first place since prescribing smoking cessation medication to every smoking patient is clearly not a standard of medical practice. In fact, in my opinion, the clinical practice guideline is a highly biased analysis that would be a public health disaster if implemented nationally. It was prepared by experts with severe conflicts of interests with Big Pharma and it has no place in guiding physicians. In fact, they would be better off ignoring it.

I guess I would be a good witness for the defense if ASH is successful in bringing any of these lawsuits.

Thursday, June 05, 2008

The support of the public health community for the FDA tobacco legislation currently before Congress continues to crumble. Last week, the National African American Tobacco Prevention Network (NAATPN) withdrew its support from the bill. Yesterday, seven former federal health secretaries wrote to every U.S. Senator, urging them to oppose the FDA legislation because of its sell out to Big Tobacco in exempting menthol from the list of flavorings banned in tobacco products.

A lead article in the New York Times today explains that the menthol exemption is a compromise agreed to by public health groups (led by the Campaign for Tobacco-Free Kids, American Heart Association, American Lung Association, American Cancer Society, and American Medical Association) in order to garner support from Philip Morris. But the former health secretaries see this compromise as a sell out to Big Tobacco and they oppose the legislation with the menthol exemption intact.

A chief sponsor of the bill - Representative Henry Waxman - admitted that the menthol exemption was a compromise of the public's health to protect the ability of adults to smoke menthol cigarettes: "...giving the FDA the authority to ban menthol [but not banning it along with the other flavorings] is the best way to balance both public health considerations with the reality that many adults only smoke menthol cigarettes."

According to the article: "The letter reflects a growing controversy over the bill’s current exemption of menthol from a list of banned flavorings — an exemption some lawmakers said was intended to garner support from Philip Morris. ... Some antismoking advocates have said they see the menthol exemption as a necessary compromise toward getting the legislation passed, and they have said that the bill as currently drafted would give the F.D.A. the authority to limit or eliminate additives, including menthol, if they are proved to be harmful. As now written the legislation would ban cigarettes flavored with strawberry, chocolate and a number of other fruit, candy and spice flavorings. Those flavorings have occasionally been added to cigarettes in what critics say are a lure to children. But the bill specifically protects menthol from the ban, even though menthol is the most widely used flavoring."

The letter to Congress members states: "Banning flavored cigarettes, which mask the harshness of tobacco--something that can deter some first-time smokers, especially children--is a positive move. But, by failing to ban menthol, the bill caves to the financial interests of tobacco companies and discriminates against African Americans—the segment of our population at greatest risk for the killing and crippling smoking-related diseases. It sends a message that African American youngsters are valued less than white youngsters."

The Rest of the Story

In my view, this is a fatal blow to the FDA tobacco legislation for this year. The publicity that the menthol exemption is receiving and the ostentatious and definitive display of dissent from prominent and well-respected public health leaders have destroyed the chances of this legislation moving forward during the current Congressional session, which faces an abbreviated schedule because of the presidential election this fall.

Now that the bill's sellout to Big Tobacco has been placed on the front page of the New York Times, the Campaign for Tobacco-Free Kids can no longer hide the truth about the legislation, which it has attempted to do (largely with success) for the past two years.

Public opinion cannot tolerate a sellout to Big Tobacco; therefore, the bill cannot pass with the menthol exemption in place. However, to remove the menthol exemption would eliminate Philip Morris' support for the bill and detract enough legislators from supporting the legislation to spell its certain doom.

Even entertaining a menthol exemption amendment on the floor of the House and/or Senate would be a political disaster for members of Congress. Supporters of the legislation would be forced to show their hand - revealing their willingness to sell out the protection of the public's health for the protection of Big Tobacco profits. Voting against the amendment would be disastrous politically. However, voting for the amendment would essentially assure the bill's death, since Congress certainly does not have the will to stand up for the public's health over the preservation of cigarette sales and industry profits.

My guess is that supporters of the legislation will choose not to bring the bill forward to the floor during this session because of the embarrassment that would come with either failing to consider the removal of the menthol exemption, voting to retain the exemption, or having the bill fail to move forward because of the removal of the exemption. It is a lose-lose-lose proposition politically and I predict that the bill's chief sponsors in Congress will take the easy road by allowing the legislation in its current form (i.e., an ill-conceived deal between Tobacco-Free Kids and Philip Morris) to disappear via a slow and quiet death.

This, I believe, is a good thing, because it will allow the tobacco control and public health community to go back to the drawing board and actually engage in a discussion about what federal tobacco legislation would be the most effective in addressing the morbidity and mortality caused by tobacco products.

I will have more to say about that in the days to come; however, for now let me just say that placing tobacco products under the regulatory authority of the FDA is not and should not be the cornerstone of such a federal legislative approach to the tobacco problem. The sooner the tobacco control community can put to bed the notion that giving the FDA the authority to regulate tobacco products is the most effective solution to the problem, the quicker we will be able to come up with an approach that may actually be able to do something to reduce smoking and save lives.

The rest of the story is that there are a lot of enemies that the Campaign for Tobacco-Free Kids can defeat. I believe it has the resources and wherewithal to take on Big Tobacco. But there is one war that even the Campaign for Tobacco-Free Kids cannot win: a battle against the truth.

When your entire campaign is based on dishonesty and deception, secrecy and exclusion, and propaganda devoid of substance, you are eventually going to get called on it. Ultimately, what is going to end up killing the FDA legislation is nothing other than the plain old ugly truth.

Tuesday, June 03, 2008

In an article in the Atlanta Journal-Constitution, the Campaign for Tobacco-Free Kids defends the menthol exemption in the FDA tobacco legislation, arguing that this exemption is necessary to protect the public's health by allowing the 10 million people in the U.S. who smoke menthol cigarettes to have continued access to these deadly products.

Sounding more like a tobacco company concerned over its profits than a public health group, the Campaign argued that it is important to protect smokers' access to the products they use, even though removing such products would likely lead to a reduction in smoking by stimulating a wave of smoking cessation. The Campaign argued against such a strong public health measure, warning that removing products which people actually use could lead to the development of a black market or other unspecified behaviors.

According to the article: "'No one in the public health community is aware the treatment of menthol was for any other reason than a concern for public health,' said Matthew Myers, president of the Campaign for Tobacco-Free Kids, a major anti-smoking group supporting the legislation. The bill bans candy flavorings because they are new to the market and have potential for widespread appeal among children, he said. 'Unlike the candy flavors, there's more than 10 million people in the United States who smoke menthol cigarettes,' Myers said. 'If you immediately withdrew a product so many people use and are addicted to, you can't say for certain what the reaction would be,' Myers said. It might cause people to quit smoking, he said, but it might also lead to illegal trafficking in menthol cigarettes or other behavioral changes. 'Would these smokers look to get their fix from other nonmentholated cigarettes or would they start to use another substance?" asks an issue paper circulated by the Campaign for Tobacco-Free Kids. The document states the organization's position that menthol should not be immediately banned because it 'would negatively impact the public's health.'"

According to the article, other public health advocates were not buying the Campaign's explanation:

"'That's "poppycock," said Sullivan, whose outspoken criticism in 1990 contributed to R.J. Reynolds scrapping a plan for a new cigarette called Uptown specifically targeted at black consumers. At the time he was serving as health secretary for then-President George H.W. Bush. 'That's the kind of statement I would expect to be issued by a tobacco company, not a health-advocacy group working to ban flavorings from cigarettes,' Sullivan said. Sullivan and some other African-American health leaders worry the controversy over menthol could derail what they otherwise believe is landmark public health legislation. But they said they are speaking out because the lax approach to menthol fails to fairly protect the health of black Americans. 'I'd much rather have a bill that's the right bill than a flawed bill,' Sullivan said."

The Rest of the Story

The Campaign for Tobacco-Free Kids' defense of the menthol exemption reveals the complete folly of the FDA legislation. The Campaign, which is boasting about how the legislation will protect children by getting rid of cigarette flavorings and saving "countless lives," was now forced to admit that the flavorings ban - which affects additives like cherry, chocolate, and strawberry - is in the bill because nobody smokes those cigarettes. The flavorings which actually do induce and support smoking are not included in the bill, according to the Campaign, because people actually smoke those products.

We certainly wouldn't want to do anything that might actually reduce cigarette consumption. Especially when we have negotiated a bill with Philip Morris, whose profits would fall if cigarette use actually declined.

So instead, the Campaign is throwing its weight behind a bill which does nothing substantive, but which has a lot of flowery "flavorings" around the edges.

For every major action that the FDA could potentially take that would actually make a real dent in smoking, Philip Morris and its "friends" at the Campaign for Tobacco-Free Kids have made sure that there is a loophole or exemption present that would mitigate the effect of the regulations on tobacco use.

The bill bans a host of flavorings which the Campaign now admits nobody uses anyway, but the flavoring which companies actually rely upon to maintain their cigarette sales is exempt.

The bill allows the FDA to regulate the sale of cigarettes, but not at any particular type of retail outlet, such as a pharmacy, convenience store, or youth community center.

The bill allows the FDA to regulate the sale of cigarettes to minors, but FDA cannot raise the legal age of cigarette purchase.

The bill allows the FDA to regulate the nicotine levels in cigarettes, but not to get rid of the nicotine altogether.

The bill allows the FDA to regulate cigarette advertising, but no regulations that would be consistent with the Supreme Court's interpretation of the First Amendment would put any kind of a dent in youth smoking.

In other words, the bill is full of marginal changes that allow the Campaign to engage in its propaganda stating how many lives the legislation will save. But if you actually take a look at any given area of potential regulation, you'll find out that the loopholes inserted to protect Philip Morris result in a bill that will do nothing to actually reduce smoking, but a whole lot to institutionalize cigarette consumption and protect existing cigarette market shares.

This is what happens when you sit down to negotiate legislation like this with Big Tobacco. You end up with an approach that says: we'll get rid of all the flavorings that Big Tobacco is not using anyway, and we'll exempt flavorings that companies are actually using.

The insanity of this approach cannot be over-emphasized: flavorings are a problem because they support smoking, so let's get rid of all the flavorings in cigarettes that no one smokes, but when we have an identified flavored product smoked by literally millions of people - where we could actually reduce smoking - let's not touch it lest we actually succeed in reducing smoking.

In fact, the Campaign for Tobacco-Free Kids' rationale for the menthol exemption is so absurd that it leads me to suspect that they actually are just making it up at the last minute to avoid having to admit that they have agreed to compromises in the legislation to appease Philip Morris.

Interestingly, this is the first we've heard from the Campaign on the need to keep flavorings on the market lest cigarettes which people actually smoke be removed from the market. It appears to be an eleventh hour excuse, made only in the face of a New York Times investigation into whether the Campaign agreed to this compromise to appease Philip Morris.

Apparently, the Campaign felt that such an admission would be very damning. What the Campaign failed to realize, I believe, is that by going to such a far-fetched excuse to avoid that admission, the Campaign has both revealed the absurdity of the legislation it is supporting and tipped us off that the suspicion of a tainted compromise is the truth after all.

Like Dr. Sullivan, I and every other tobacco control advocate with whom I have spoken feel that the Campaign's justification for the menthol exemption is poppycock. It sounds like something you would hear out of the mouths of Big Tobacco, not from a leading anti-smoking group.

If I actually believed that the Campaign truly believes what it is saying, I would argue here that the Campaign is not actually interested in protecting the public's health. I would argue that the Campaign is more interested in protecting tobacco sales than in actually supporting an aggressive action that might well reduce smoking.

Luckily, I don't believe, for a minute, that the Campaign truly believes in its poppycock explanation that we need to protect the sale of cigarettes to addicted smokers. I think that the Campaign was backed into a corner and concocted this flimsy explanation out of pure desperation.

However, the damning truth that the Campaign was apparently trying to avoid is now becoming clearer to the nation day by day: the Campaign for Tobacco-Free Kids struck a deal with Philip Morris after negotiating the FDA legislation with the nation's largest cigarette company and in forging that deal, the Campaign compromised the protection of the public's health for the special protection of tobacco company financial interests.

The truth is ugly, but perhaps not as ugly as the appearance that the Campaign for Tobacco-Free Kids is actually working on the side of the tobacco companies.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 25 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.